NCT06373991Not yet recruitingPhase 1
A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus
A Phase 1 Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Moderate or Severe Systemic Lupus Erythematosus
Source: ClinicalTrials.gov · Last updated 17 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is: • To evaluate the safety and tolerability of ATHENA CAR-T. After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 9 Apr 2024
- Start date
- 24 Jul 2024
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- EdiGene Inc.
- Diseases
- Lupus (SLE)
- NCT number
- NCT06373991
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 24 Jul 2024 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- within 8 weeks before screening, had CNS disease caused by SLE or non-SLE diseases;
- within 8 weeks before screening, had lupus crisis;
- has following kidney diseases: within 8 weeks before randomization, had SLE with serious kidney involvement or need treatment using medications prohibited by protocol to treat active nephritis, or need hemodialysis or need treatment by prednisone MT 100mg/d for longer than 14d or equivalent therapy;
Other illness
- Had or has active malignancy;
- had serious allergy to any lymphodepletion medication or ingredients of ATHENA CAR-T;
- has uncontrolled fungi, bacterial or viral infection or other infections investigator deemed not suitable to participate in the study;
- combined with other autoimmune disease that needs treatment;
Other
- pregnant or lactating women;
- has other factors that deemed not suitable by investigator.
Who the study is looking for
- Male or Female, between 18 and 56 years old;
- diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
- anti-Nuclear Antigen Ab positive (titer NLT 1:80) and/or dsDNA ab positive and/or Anti-Sm ab positive at screening;
- at screening, SLEDAI-2000 scoring NLT 8 points, if low complement scoring and/or anti-dsDNA ab scoring is available, the SLEDAI-2000 scoring except low complement and anti-dsDNA ab should be NLT 6 points;
- should be subjected to at least 6 months of standard treatment for SLE, and disease active at least two months before screening;
- good organ functions;
- trial participants whose partner is fertile agree to use effective contraceptives til 24 months post transfusion, fertile female participants should have negative urine/blood pregnancy test results (participants who were sterilized or menopause for MT 12 months is not considered fertile);
- voluntary participates this trial and can comprehend and sign ICF.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.